PEG-rhG-CSF预防化疗后中性粒细胞减少症的随机对照临床研究  

Treatment of chemotherapy-induced neutropenia with pegylated recombinant human granulocyte colony-stimulating factor: a randomized controlled phase II clinical study

作　　者：张百红[1] 岳红云[2] 王琴中[1] 徐佳维[1] 杨文元[1] 马澜婧[1] 

机构地区：[1]兰州军区兰州总医院肿瘤科,甘肃兰州730050 [2]兰州军区兰州总医院眼科,甘肃兰州730050

出　　处：《西北国防医学杂志》2013年第1期39-41,共3页Medical Journal of National Defending Forces in Northwest China

摘　　要：目的:比较聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)和重组人粒细胞集落刺激因子(rhG-CSF)预防化疗后中性粒细胞减少症的有效性和安全性。方法:采用随机开放、平行分组的方法,乳腺癌患者接受1个周期TAC方案化疗,随机分配到60、100、120μg/kg PEG-rhG-CSF组和5μg/(kg.d)rhG-CSF组。结果:共入组12例,5μg/(kg.d)rhG-CSF对照组和60、100、120μg/kg PEG-rhG-CSF试验组患者ANC<1.5×109/L分别持续1、2、2和2.75 d,中性粒细胞减少症的发生率差异无统计学意义。受试药物的第2峰低于对照药物。结论:PEG-rhG-CSF一次给药的疗效和不良反应与rhG-CSF多次给药相似。Objective ：To compare the efficacy and safety of daily administration of recombinant human granulocyte colony -stimulating factor （rhG - CSF） with single subcutaneous injection of pegylated recombinant human granulocyte colony - stimulating factor （ PEG - rhG - CSF） in patients with chemotherapy - induced neutropenia. Methods： In the randomized open -label study, 12 breast cancer patients receiving chemotherapy with TAC regimen were randomly divided into 4 groups. The patients in group A received a single subcutaneous injection of rhG - CSF from day 3 to 16. The patients in group B, C, D received subcutaneous injection of PEG - rhG - CSF （daily 60, 100 and 1201xg/kg respectively） on day 3. Results： The duration of neutropenia （absolute neutrophil count 〈 1.5 x 109/L） in group A, B, C and D were 1, 2, 2 and 2.75 days, respectively （P 〉0.05）. Compared with group B, C and D, the profile of absolute neutrophil count exhibited the second peak in group A. Conclu- sion ： A single subcutaneous injection of PEG - rhG - CSF provides neutrophil support and a safe profile comparable to regimen of daily subcutaneous injection of rhG - CSF in breast cancer patients receiving chemotherapy.

关 键 词：乳腺肿瘤 化疗 聚乙二醇化重组人粒细胞集落刺激因子 中性粒细胞减少 

分 类 号：R730.5[医药卫生—肿瘤]